Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Osteoporosis

Prolia(R): 60 mg subcutaneously once every 6 months

Comments:
-If a dose is missed, the injection should be administered as soon as possible. Thereafter, injections should be scheduled every 6 months from the date of the last injection.
-This drug should be injected into the upper arm, upper thigh, or abdomen.

Uses:
-Treatment of postmenopausal women with osteoporosis at high risk for fracture
-Treatment to increase bone mass in men with osteoporosis
-Treatment of bone loss in men receiving androgen deprivation therapy for prostate cancer
-Treatment of bone loss in women receiving adjuvant aromatase inhibitor therapy for breast cancer

Usual Adult Dose for Giant Cell Tumor of Bone

Xgeva (R):
120 mg subcutaneously every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy

Comments:
-This drug should be injected into the upper arm, upper thigh, or abdomen.
-Calcium and vitamin D should be administered to treat or prevent hypocalcemia.

Use: Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity

Usual Adult Dose for Osteolytic Bone Metastases of Solid Tumors

Xgeva(R): 120 mg subcutaneously every 4 weeks

Comments:
-This drug should be injected into the upper arm, upper thigh, or abdomen.
-Calcium and vitamin D should be administered to treat or prevent hypocalcemia.

Use: Prevention of skeletal-related events in patients with bone metastases from solid tumors

Usual Adult Dose for Hypercalcemia of Malignancy

Xgeva(R): 120 mg subcutaneously every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy

Comment:
-This drug should be injected into the upper arm, upper thigh, or abdomen.

Use: Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy

Usual Pediatric Dose for Giant Cell Tumor of Bone

Xgeva (R):
120 mg subcutaneously every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy

Comment:
-Xgeva (R) was studied in adolescent patients aged 13 to 17 years with giant cell tumor of bone who had reached skeletal maturity, defined by at least 1 mature long bone (e.g., closed epiphyseal growth plate of the humerus), and had a body weight of 45 kg or more.

Renal Dose Adjustments

Mild to moderate renal dysfunction: Data not available.
Severe renal dysfunction (CrCl less than 30 mL/min): Use with caution.
.

Liver Dose Adjustments

Data not available

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Prolia. It includes a medication guide, and a communication plan. For additional information: www.fda.gov/REMS

Safety and efficacy have not been established in patients younger than 18 years, except skeletally mature adolescents with giant cell tumor of bone [only for Xgeva (R)].

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Administer injection in the upper arm, the upper thigh, or the abdomen. Adequately supplement all patients with calcium and vitamin D.
-People sensitive to latex should not handle the grey needle cap on the single-use prefilled syringe, which contains dry natural rubber (a derivative of latex).
-This drug should not be administered intravenously, intramuscularly, or intradermally.

Storage requirements:
-Store this drug in a refrigerator at 2C to 8C (36F to 46F).
-Do not freeze.
-Prior to administration, this drug may be allowed to reach room temperature (up to 25C/77F).
-Once removed from the refrigerator, this drug should not be exposed to temperatures above 25C/77F and should be used within 14 days.
-Protect from direct light and heat.